The Focused Ultrasound Foundation today announced a new clinical trial investigating the use of focused ultrasound technology in treating patients with tremor-dominant Parkinson's disease. Funded in part by the Foundation, the study has treated its first two patients at the University of Virginia to evaluate the noninvasive technology's safety and effectiveness in alleviating medication-resistant Parkinsonian tremors.
The trial, led by principal investigator W. Jeffrey Elias, M.D., a University of Virginia neurosurgeon, is an FDA-approved double-blinded protocol study under which 30 patients are being randomly assigned to either treatment or control groups and followed for one year. The subjects are undergoing an investigational procedure that targets a small area deep within the brain using focused sound waves guided by a magnetic resonance scanner. The noninvasive process uses no scalp incisions, electrodes or general anesthesia, allowing patients to remain awake and communicative; it has the potential to be a significant improvement over the current standard of care, which requires surgical implementation of a pacemaker in the brain.
"This study is the next step in the Foundation's roadmap for developing a noninvasive treatment for patients with Parkinson's disease," said Focused Ultrasound Foundation Chairman Neal F. Kassell, M.D. "An effective therapy that works without incisions could transform the treatment of this debilitating condition. Supporting this research is consistent with our objective of getting focused ultrasound into the hands of clinicians who can implement the technology to save and improve the lives of patients around the world."